Device, apparatus, and prosthesis for suturless anastomosis

ABSTRACT

The invention concerns a device for temporary coupling an anastomosis prosthesis to an anastomosis apparatus, a deployment apparatus and a prosthesis for performing suturless anastomosis. Coupling of the anastomosis prosthesis to the coupling device is performed by suction and coupling of the coupling device to the deployment tube is performed by a fixation and a fastening mechanism.

RELATED APPLICATION

[0001] The patent application claims priority from U.S. ProvisionalPatent Application Serial No. 60/222,051 filed on Jul. 31, 2000, theentire disclosure of the application being expressly incorporated hereinby reference.

TECHNICAL FIELD

[0002] The invention disclosed in the patent application concerns adevice for temporary coupling an anastomosis prosthesis to a deploymentapparatus, a deployment apparatus and a prosthesis for suturlessanastomosis, and methods for using the said devices for the saidpurpose.

BACKGROUND ART

[0003] A simple method for joining one hollow organ end-to-side toanother hollow organ, without interrupting fluid follow in the efferentorgan has long been desired in the medical practice, particularly in thefield of cardiovascular surgery. Conventional methods for joining(anastomosing) two blood vessels in an end-to-side configurationinvariably necessitates halting blood flow in the efferent or outflowblood vessel, jepoardising the viability of tissues perfused by theoutflow blood vessel. To overcome this drawback, a surgical techniquehas been described in medical literature that involves the stitching ofa metal ring to the outflow vessel (Tulleken CAF, et. al. Acta Neurochir1995; 134:66-70), and a tubular prosthesis to the inflow or afferentlimb of the anastomosis. The later is stitched to the metal ring, andluminal continuity established with the help of optical energytransmitted by a catheter passed through the tubular prosthesis. Thecomplexity of the procedure has hindered its adoption by surgeons.

[0004] Hence the use of a biocompatible adhesive instead of stitches hasbeen advocated and devices exploiting the idea have been disclosed inPCT/NO99/00093.

[0005] The present invention extends this concept further by providingthe means for implanting a prosthesis on a blood vessel without the needfor manipulation of the blood vessel, making performance ofremote-controlled, robot-assisted vascular anastomosis a clinicallyrealistic proposition.

[0006] The device for temporary coupling an anastomosis prosthesis to ananastomosis apparatus according to the invention comprises:

[0007] a ring shaped member consisting of at least one ring section,wherein each ring section comprises at least one radial partition wallsdefining at least two chambers, and a common upper chamber limited by asection roof, wherein the chambers are adapted for aposing to theanastomosis prosthesis and fastening to said prosthesis by means of asuction pressure, wherein the common upper chamber provides a channel influid connection with the chambers,

[0008] a tubing connection assembly in fluid connection with saidchannel for transmitting a suction pressure from a suction apparatus tothe chambers, and

[0009] a fixation mechanism for fastening the ring shaped member to ananastomosis apparatus. The coupling device is thus meant for attachmentto the prosthesis by suction, where the floor of the at least onesection is apposed to the prosthesis.

[0010] There are several alternative ways of fastening the couplingdevice to the anastomosis apparatus, but all embodiments have the commonfeature that they permit easy, secure and precise fastening of theseparts together.

[0011] The invention comprises also an anastomosis apparatus which inone embodiment comprises a coupling device that is an integrated part ofthe apparatus. In this case the fixation mechanism in the couplingdevice is not adapted for temporarily attachment to the apparatus.

[0012] Back to the coupling device, in a first embodiment of theinvention the coupling device comprises a fixation mechanism with:

[0013] an attachment plate with a rectangular projection or offsetblock, the attachment plate and the offset block being perforated, and

[0014] a threaded fixation pin through the attachment plate and theoffset block, where the pin is provided on or in the vicinity of one endwith a nut and on or in the vicinity of the other end with a fixationplate,

[0015] where the offset block and the fixation plate are meant to betightened against an outer and an inner surface respectively in adeployment tube in the apparatus by means of the pin.

[0016] In a second embodiment of the invention the fixation mechanismcomprises:

[0017] an attachment plate with a rectangular projection or offsetblock, and

[0018] a fixation pin extending between the offset block and a fixationplate,

[0019] where the offset block and the fixation plate are meant to bearranged against an outer and an inner surface respectively in adeployment tube in the apparatus.

[0020] In a third embodiment the fixation mechanism comprises:

[0021] a torsion spring, where one limb of the torsion spring isattached to the fixation plate and the other limb is accommodated in agroove in the offset block,

[0022] where the torsion spring is meant for pushing the fixation pininto a fixation slot in a deployment tube in the fixation apparatus.

[0023] In a fourth embodiment the fixation mechanism comprises a bentresilient wire in stead of a torsion spring, where one limb of the wireis attached to the fixation plate and the other limb is accommodated ina groove in the offset block, where the resilient wire is meant forpushing the fixation pin into a fixation slot in a deployment tube inthe fixation apparatus.

[0024] In a fifth embodiment the fixation mechanism comprises:

[0025] an attachment plate with a rectangular projection or offsetblock, and

[0026] a polymer hook or loop patch bonded to the offset block,

[0027] where the hook patch is meant for fastening the offset block to acorresponding polymer loop or hook patch on a deployment tube in theanastomosis apparatus.

[0028] In a sixth embodiment the fixation mechanism comprises:

[0029] an attachment plate with a rectangular projection or offsetblock, and

[0030] a flat magnet bonded to the offset block,

[0031] where the flat magnet is meant for fastening the offset block toat least one corresponding ferromagnetic patch on a deployment tube inthe anastomosis apparatus.

[0032] In a preferred embodiment of the invention the chambers areprovided with a mesh on the surface adapted for aposing to theanastomosis prosthesis.

[0033] As stated before the invention also includes a deploymentapparatus for suturless anastomosis between two hollow organs by meansof an implantable anastomosis prosthesis and a prosthesis couplingdevice comprising:

[0034] a targeting tube,

[0035] a deployment tube provided with a fastening device forcooperation with a fixation mechanism in the prosthesis coupling device,for fastening said prosthesis coupling device to said deployment tube,

[0036] a flow control valve for controlling fluid flow in and out of theapparatus, wherein the inlet of the valve is adapted for connection to asuction apparatus, and a first outlet of the valve is coupled to a fluidconnecting device adapted for connection to a corresponding tubingconenction assembly in the anastomosis coupling device,

[0037] a flow control lever for controlling flow through said valve, and

[0038] a trigger for displacing the deployment tube in relation to thebody of the apparatus,

[0039] a device for connecting the apparatus to a suction apparatus.

[0040] As one can see, the apparatus according to the invention has atargeting tube that permits a precise localisation of the apparatus atthe anastomosis site, a deployment tube for receiving the couplingdevice and thus the prosthesis, and two triggering/control devices forcontrolling on one side suction pressure to be exerted by the couplingdevice against the anastomosis prosthesis and on the other side themovement of the prosthesis towards the anastomosis site. In oneembodiment the targeting tube is adapted for applying suction to theorgan to be anastomosed, thereby securing a stationary location of theapparatus. In another embodiment the apparatus is adapted for apposingthe anastomosis prosthesis to the target organ with positive pressure.

[0041] In a first embodiment of the apparatus, adapted for use togetherwith the first to fourth embodiments of the coupling device, thefastening device consists of at least one fixation slot extending fromthe edge of the deployment tube.

[0042] In a second embodiment of the apparatus, specially adapted foruse together with the second embodiment of the coupling device eachfixation slot comprises a long limb, a fixation fluke, a transverse limband a short limb, where the fixation fluke is meant for securing afixation pin in a fixation mechanism in the prosthesis coupling deviceinto the short limb of the fixation slot.

[0043] In a third embodiment of the apparatus, specially adapted for usetogether with the third embodiment of the coupling device each fixationslot comprises a long limb, a transverse limb and a short limb, wherethe short limb is meant for receiving a fixation pin in a fixationmechanism in the prosthesis coupling device.

[0044] In a fourth embodiment of the apparatus, adapted for use togetherwith the fifth embodiment of the coupling device the fastening deviceconsists of at least one loop or hook polymer patch arranged on thedeployment tube for fastening to a corresponding hook or loop patch in afixation mechanism in the prosthesis coupling device.

[0045] In a fifth embodiment of the apparatus, adapted for use togetherwith the sixth embodiment of the coupling device the fastening deviceconsists of at least one ferromagnetic patch arranged on the deploymenttube for fastening to a corresponding magnet in a fixation mechanism inthe prosthesis coupling device.

[0046] In a preferred embodiment, the apparatus comprises an inlet forintroduction of imaging or flow measuring devices.

[0047] As stated before, in another preferred embodiment of theinvention the second outlet of the flow control valve is coupled to theinside of the targeting tube for transmitting a suction pressure to saidtargeting tube.

[0048] In another embodiment the apparatus comprises a prosthesiscoupling device according to the invention as an integrated element ofthe apparatus.

[0049] The invention also includes an implantable anastomosis prosthesiscomprising a first tubular member to be placed around a first organ, anda flat sheet or attachment member to be placed on a second organ,wherein the luminal or inner surface of the tubular member is continuouswith the surface of the flat member facing the second organ. Theprosthesis according to the invention comprises a second tubular memberattached to the first tubular member for facilitating insertion of ananastomosis instrument in the prosthesis.

[0050] Use of the apparatus according to the invention will now bedescribed briefly:

[0051] 1) The coupling device is attached to the deployment tube,

[0052] 2) the targeting tube is introduced into the side-arm of theanastomosis prosthesis,

[0053] 3) the prosthesis is slid up the targeting tube till theprosthesis flat member abuts the coupling device,

[0054] 4) the coupling device is fastened to the prosthesis,

[0055] 5) the apparatus is introduced into the body and the tip of thetargeting tube is placed at the chosen side for anastomosis,

[0056] 6) the triggering device is pressed activating the actuator, andthe deployment tube is longitudinally displaced along the targeting tubetowards the organ, thereby delivering the mounted anastomosis prosthesisto the organ,

[0057] 7) the anastomosis prosthesis is pressed against the organ,

[0058] 8) the coupling device is detached from the anastomosisprosthesis.

[0059] As one can see the coupling device permits temporary coupling theprosthesis to the deployment tube. This temporary coupling is performedby establishing suction pressure between the coupling device and theprosthesis. When the prosthesis is in place, the suction pressure iseliminated and the prosthesis is no longer fastened to the couplingdevice. In a further preferred embodiment of the invention the pressureis increased after the prosthesis is in place and thus the couplingdevice is used as a means for pressing the anastomosis against theorgans.

[0060] The apparatus according to the invention combines pure amechanical part for delivering the prosthesis to the anastomosis siteand a fluid driven part for fastening the coupling device to theprosthesis, optionally fastening the targeting tube to the organ and ina preferred embodiment pressing the prosthesis against the organ.

[0061] The various embodiments of the invention will now be describedwith reference to the attached drawings, where:

[0062]FIG. 1 is a perspective view of a first embodiment of theanastomosis prosthesis.

[0063]FIG. 2 is a longitudinal section of the embodiment in FIG. 1 alonglong axis of side-arm.

[0064]FIG. 3 is a perspective view of a second embodiment of theanastomosis prosthesis.

[0065]FIG. 4 is a perspective view and a partial cut of a thirdembodiment of the anastomosis prosthesis.

[0066]FIG. 5 is a perspective view of a fourth embodiment of theanastomosis prosthesis.

[0067]FIG. 6 is a longitudinal section of said fourth embodiment ofanastomosis prosthesis along long axis of side-arm.

[0068]FIG. 7 is a perspective view of a fifth embodiment of theanastomosis prosthesis according to the present invention.

[0069]FIG. 8 is a longitudinal section of said fifth embodiment ofanastomosis prosthesis along long axis of side-arm.

[0070]FIG. 9 is a perspective view of an embodiment of apparatusaccording to the invention.

[0071]FIG. 10 is a longitudinal section of said embodiment of theapparatus.

[0072]FIG. 11 is a transverse cross section (through spring compressionplate) of preferred (first) embodiment of instrument.

[0073]FIG. 12 is a cross-section (through first and second outlet ports)of a 3-port valve in a first position.

[0074]FIG. 13 is a cross-section (through first and second outlet ports)of the 3-port valve in FIG. 12 in a second position.

[0075]FIG. 14 is a longitudinal section (through first and second outletports) of the 3-port valve in FIG. 12 in the second position.

[0076]FIG. 15 is a cross-section of the coupling device through suctionchambers.

[0077]FIG. 16 is a cross-section of the coupling device through freeedges.

[0078]FIG. 17 is a longitudinal para-tangential section of the couplingdevice through three adjacent suction chambers.

[0079]FIG. 18 is a longitudinal section of the apparatus, the couplingdevice and the prosthesis according to the invention and shows the fluidcircuit.

[0080]FIG. 19 is a longitudinal radial section of the coupling devicethrough fixation screw and connection plug.

[0081]FIG. 20 is a cross-section through fixation screw of attachmentplate of the coupling device.

[0082]FIG. 21 is a longitudinal section of the coupling device throughfixation screw.

[0083]FIG. 22 is a cross-section of the coupling device throughattachment plates.

[0084]FIG. 23 is a perspective view of a first embodiment of free end ofdeployment tube.

[0085]FIG. 24 is a longitudinal section (through fixation pin) offixation plate of coupling device mounted on deployment tube.

[0086]FIG. 25 is a cross-section (through fixation pin) of fixationplate of coupling device hood mounted on deployment tube.

[0087]FIG. 26 is a longitudinal section of a preferred embodiment of theapparatus carrying two suction hoods.

[0088]FIG. 27 is a longitudinal cross-section of a preferred embodimentof the apparatus (carrying two suction hoods) with trigger pressed.

[0089]FIG. 28 is a longitudinal section of the attachment plate throughfixation pin in a second embodiment of the coupling device.

[0090]FIG. 29 is a perspective view of the free end of the deploymenttube in a second embodiment of the apparatus.

[0091]FIG. 30 is a longitudinal section of the attachment plate throughtorsion spring in a third embodiment of the coupling device.

[0092]FIG. 31 is a cross-section of the attachment plate along the freeend of the torsion spring in said third embodiment.

[0093]FIG. 32 is a perspective view of the free end of deployment tubein a third embodiment of the apparatus.

[0094]FIG. 33 is a longitudinal cross-section (through torsion spring)of fixation plate of a suction hood mounted on the deployment tube.

[0095]FIG. 34 is a longitudinal radial section (through fixation pin) ofa fifth and a sixth embodiment of the coupling device mounted on thedeployment tube.

[0096]FIG. 35 is a perspective view of the free end of deployment tubeof a fifth embodiment of the apparatus.

[0097]FIG. 36 is a perspective view of free end of the deployment tubein another embodiment of the apparatus.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTIONAnastomosis Prosthesis

[0098]FIGS. 1 and 2 show a first embodiment of the anastomosisprosthesis for use in the present invention. In this embodiment theprosthesis comprises a tubular member (side-arm) 1 that is attached to aflat, pliable sheet (attachment member) 2 at an acute angle or at 90°,such that the luminal or inner surface 3 of the side-arm 1 is continuouswith the far surface (attachment surface) 4 of the attachment member 2,that is the surface of the attachment member facing the second organ. Anopening (ostium) 5 in the attachment member 2 matches thecross-sectional area of the lumeni of the side-arm 1.

[0099] The attachment surface 4, or the luminal surface 3, or both arepreferably lined with a biocompatible adhesive, or one or multiplepharmacologic agents or both.

[0100]FIG. 3 shows a second embodiment of the prosthesis, wherein theend of the side-arm I continuous with the attachment member 2 isreinforced with a metal collar 6, that may have thermodynamicshape-memory.

[0101]FIG. 4 shows a third embodiment of the prosthesis wherein theside-arm 1 is reinforced with a cylindrical mesh 7 of a metal withthermodynamic shape-memory.

[0102]FIGS. 5 and 6 show a fourth embodiment of the prosthesis. In thisembodiment, the side-arm 1 is parallel to the attachment member 2, andhas a side-hole 9, that is circumferentially continuous with the ostiumor opening 5 in the attachment member 2.

[0103]FIGS. 7 and 8 show a fifth embodiment of the prosthesis. Here, asecond tubular member (apparatus inlet) 9 is connected to the side-arm1, such that the opening (apparatus port) 10 between the side-arm 1 andthe apparatus inlet 9 projects on the ostium 5 along the long axis ofthe apparatus inlet 9.

[0104] The attachment member 2 is preferably provided with visualmarkers to help align the prosthesis satisfactorily with the organ.

Apparatus and Coupling Device

[0105]FIG. 9 shows a first embodiment the apparatus according to theinvention. It comprises an elongated part 11 with an assembly to carrythe anastomosis prosthesis, and an outer casing (body) 12 incorporatinga hand grip 13, that contains the trigger to deploy the anastomosisprosthesis and a flow control lever 53 for controlling flow in and outof the apparatus. FIG. 9 shows also a fluid connecting device or femaledevice 57 for connection between the apparatus and the prosthesiscoupling device.

[0106] The elongated part 11 includes two sliding coaxial tubularmembers, an inner targeting-tube 14, and the deployment tube 15. Thetargeting tube 14 permits placement of the apparatus on the rightposition on one of the organs to be anastomosed, while the deploymenttube 15 carries the prosthesis and moves it into place on said organ.

[0107] Referring now to FIG. 10 that shows a longitudinal section of theapparatus, the targeting-tube 14 runs the length of the apparatus andhas a side-arm 16 near one end, this side-arm establishes a connectionbetween a flow control valve 52 and the targeting tube. The flow controlvalve 52 as will be described later is adapted for coupling to a suctionapparatus and a suction pressure can thus be transmitted vil side-arm 16to the targeting tube 14 . For this purpose the end of thetargeting-tube 14 near the side-arm 16 is fixed to the body 12 such thatthe attachment is impervious to the passage of air. The other end of thetargeting-tube 14 protrudes from body 12, and its free-edge 17 a isperpendicular to the longitudinal axis of the tube 14 or makes an acuteangle with it.

[0108] The deployment tube 15 is shorter in length than thetargeting-tube 14 and the free edge of its protruding end 17 b issubstantially congruent with the corresponding free edge 17 a of thetargeting-tube 14. At the opposite end of the deployment tube, anupwards-facing circular recess 19 is present. Forward to the recess 19,the deployment tube 15 has a coaxial collar (spring-compression plate)20 that can be seen in further detail in FIG. 11, which shows howcompression plate 20 is fixed to the deployment tube 15 by two or moreradial struts 21.

[0109] The body of apparatus 12 has the shape of a flattened cylinderwhich is closed at one end. An angulated extension near the closed-endserves as the hand-grip 13. A helical compression spring 43 is coaxiallymounted between a narrow collar oil the inner surface of the body(spring-retention collar) 44, and the spring-retention plate 20 of thedeployment tube 15, distracting the retention collar 44 from theretention plate 20. Behind the spring-retention collar, is a pivot pin45 supporting a substantially linear member (pivoting lever) 46. Fixedto the lower end of the pivoting lever 46 is a spherical member(weighting sphere) 47, whose weight applies counter-clockwise torque onthe pivoting lever 46. The other end of the pivoting lever is in contactwith the inner surface of the body 12 and is thereby restrained fromfree counter-clockwise rotation. Hinged via a pivot pin 48 to a pair ofbrackets in the hand-grip 13, and biased by a torsion spring 49, is alever designed to accommodate the fingers (trigger) 50. A <<L?> shapedmember, (trip lever) 51 extends from the trigger 50 within the lumen ofthe body 12, in the direction of the upper end of the pivoting lever 46.The body 12 is provided with a 3-port, 3-way valve 52, whose flowcontrol lever 53 is accessible from outside the body 12 of theapparatus, the flow control lever 53 being the trigger of the fluiddriven part of the apparatus.

[0110]FIGS. 12, 13 and 14 show valve 52 in closer detail. One outlet 54of the valve 52 is connected to the sidearm 16 of the targeting-tube 14as stated before. Another outlet 55 of the valve 52 is connected to aflexible tube (primary suction tube) 56, which ends in the femalecounterpart 57 of the male component 34 of the tubing connectionassembly that permits coupling of the coupling device to the prosthesisin a way that will be described in detail later. The female component 57of the tubing connection assembly is fixed to the deployment 15 tubenear its free edge 17 b. The inlet 58 of the valve is continuous with anexternal plug (suction plug) 59 that is suitable for connecting to asuction apparatus.

[0111] The function of the embodiment of the apparatus described abovewill be explained later in the description.

[0112]FIG. 15 shows one embodiment of the coupling device according tothe invention. This coupling device comprises a ring shaped membercomprising of at least one, and in this case two ring sections orsuction hoods 22, with similar radii of curvature. The coupling devicecan comprise more than two suction hoods 22 arranged in a circle asshown in the figure. Each suction hood 22 is divided into multiplesuction chambers 27 by radial partition walls 28. FIGS. 15 and 16 showthat each suction hood 22 has parallel inner 23 and outer 24 walls, saidwalls being connected on one edge 25 a, 25 b by a mesh 26 in a preferredembodiment of the invention. As can be seen in FIG. 17, which shows asection of a suction hood 22, each suction hood 22 comprises a roof 29which forms a ring shaped channel 30 communicating with each suctionchamber 27 and thus establishing fluid connection between each chamber27. Roof 29 (and thus ring shaped channel 30) are in fluid connectionwith a tubing connection assembly for transmitting a suction pressurefrom a connecting device to chambers 27. Said tubing connection assemblyis shown schematically in FIG. 18 and comprises a linear plug 31(connection plug) protruding from the roof 29 of the suction hood 22coupled to channel 30. To plug 31 is attached a tube (tertiary suctiontube) 32. The tertiary suction tubes from all suction hoods 22 of thering shaped member open into a single tube (secondary suction tube) 33,which in turn ends in the male component 34 of the tube connectionassembly. This male component 34 is the counterpart of the femalecomponent 57 mentioned with reference to FIGS. 9 and 10. The fluidcircuit is thus described in its entirety. Its function is to transmit asuction pressure from a suction apparatus (not shown) to suction hoods22 so that these exert a suction pressure on the anastomosis prosthesisand hold it in place on the deployment tube 15.

[0113] The suction hoods 22 are mechanically fastened to deployment tube15 by means of a fixation mechanism that will be described withreference to FIGS. 19-21 which cooperates with a fastening device in theapparatus, which fastening device will be described with reference toFIG. 23. FIG. 19 shows that at the apex of its curvature, the inner wall23 of the suction hood 22 is continuous with a short rectangular plate(attachment plate) 35 that protrudes beyond the roof 29 of the hood 22.On the inner surface of the attachment plate 35 is a flat rectangularprojection (offset block) 36. FIG. 20 shows the offset block 36 with aconcave free surface 37.

[0114]FIG. 21 shows a first embodiment of the coupling device where athreaded fixation pin (fixation screw) 39 carrying a nut 40 passesperpendicularly through the attachment plate 35 and offset block 36. Tothe tip of the fixation screw 39 is attached a convex plate (fixationplate) 41, this figure shows the curvature of the attachment plate 35,offset block 36 and fixation plate 41.

[0115]FIG. 22 shows the ring shaped member comprising two suction hoods22 and the relative positions of linear plug 31 for fluid connection,and the fixation mechanism comprising fixation plate 41, offset block36, fixation pin 39 and nut 40.

[0116]FIG. 23 shows the edge 17 b of deployment tube 15 in detail in afirst embodiment of the apparatus. This figure shows the fasteningdevice implemented as two or more short rectangular slots (fixationslots) 18 extending from the edge 17 b which are arranged symmetricallyaround the circumference of the deployment tube 15. The aim of thefixation slots 18 is to provide a seat for introduction of fixationscrew 39 in the coupling device for fastening the coupling device to thedeployment tube 15.

[0117]FIGS. 24 and 25 show in detail the relative placement of suctionhood 22 and deployment tube 15. Offset block 36 and fixation plate 41are meant to be tightened against the outer 42 and the inner 38 surfacerespectively of the deployment tube 15 in the apparatus by means of thepin 39. In other words, the free surface 37 on offset block 36 isadapted for apposing against the outer surface of deployment tube 15while the convex plate 41 is adapted to appose against the inner surface42 of deployment tube 15.

[0118] The concept behind the invention can be realised in several waysas expressed by the various alternative of the invention. Thesealternative embodiments will be described in detail later.

[0119] Use of the invention will be now described by means of an exampleof the coupling device and the apparatus as described above and withreference to FIGS. 22, 23, 24, 26 and 27.

Attachment of Suction Hood to Apparatus

[0120] Reference is now made to FIGS. 22 and 23 and 24. A suction hood22 with an appropriate radius of curvature in relation to theanastomosis prosthesis to be implanted is attached to the deploymenttube 15. In this example, the fixation screw 39 of the suction hood 22is introduced into a fixation slot 18 of the deployment tube 15, andadvanced until it reaches the floor 73 of the slot. The nut 40 on thefixation screw 39 is turned clockwise until the fixation plate 41 isclosely apposed to the luminal surface 42 of deployment tube 15, therebysecuring the suction hood to the deployment tube 15. More suction hoods22 are attached symmetrically to the deployment tube 15, the totalnumber depending on the number of available fixation slots 18 and sizeof the anastomosis prosthesis.

Implantation of Anastomosis Prosthesis

[0121] Reference will now be made to FIGS. 7, 26 and 27. After therequired number of suction hoods 22 are fixed to the deployment tube 15,the tertiary suction tubes are connected to the secondary suction tube33, and the latter is mated with the primary suction tube 56, theapparatus is cocked by manually drawing the deployment tube 15 towardsthe body 12 of the apparatus till the weighting sphere 47 engages thecircular recess 19 (FIG. 26). A suction apparatus is connected to the 5suction plug 59 (not shown) on the 3-port valve 52. The targeting-tube14 is introduced into the side-arm 1 or apparatus inlet 9 of ananastomosis prosthesis (FIG. 7), and advanced till the suction hoods 22symmetrically abut the attachment member 2 of the prosthesis. The flowcontrol lever 53 of the valve 52 is placed in position I (FIG. 26),establishing a channel between the suction apparatus and the primarysuction tube 56. The suction apparatus is powered up creating negativepressure in the suction chambers 28, securing the anastomosis prosthesisto the apparatus. The free edge 17 a of the targeting-tube 14 is placedat the desired site on the organ to be anastomosed, and aligned asappropriate. If deemed appropriate, an imaging device or aflow-measurement device may be introduced into the targeting-tube 14through an inlet 70 (not shown) and the relevant data collected toconfirm that the site selected for anastomosis is suitable. Theflow-control lever 53 is placed in position II (FIG. 27), creating anopen fluid circuit between the suction apparatus and the targeting-tube14. Negative pressure is established in the targeting-tube 14, securingit to the organ. A biocompatible adhesive is applied to the tissuesurfaces around the free edge 17 a of the targeting-tube 14. This stepmay be skipped if the attachment surface 3 of the attachment member 2 islined with an adhesive. The trigger 50 is pressed, rotating the triplever 51 forwards (FIG. 27). The tip of the trip lever 51 rotates thepivoting lever 46, elevating weighting sphere 47. The compression spring43 expands, driving the deployment tube 15 forwards, and apposing theattachment surface 4 of the anastomosis prosthesis to the organ to beanastomosed and the surrounding tissues. The flow-control lever 53 isplaced in position I, and the pressure in the suction circuit is loweredfurther. After a firm adhesive bond has been established between theanastomosis prosthesis and the tissues, the suction apparatus is powereddown. The flow control 53 lever is placed in position II, allowing thepressure in the suction circuit to return to atmospheric levels. Theapparatus is removed from the body, leaving the anastomosis prosthesisattached to the organ.

Alternative Embodiments of the Invention and Their Use

[0122] In an embodiment of the apparatus the suction hood 22 does nothave a mesh 26. The advantage of this embodiment is that the absence ofa mesh increases the suction force that is applied to the anastomosisprosthesis.

[0123]FIG. 28 shows a second embodiment of the coupling device where thefixation mechanism comprises a short pin (fixation pin) 60 with thefixation plate 41 at its tip. FIG. 29 shows a second embodiment of theapparatus where the fastening device is implemented as fixation slots 18comprising a long limb 74 for insertion of a fixation pin, a fixationfluke 74 to lock the fixation pin in place, a transverse limb 76 and ashort limb 77. In this case, the fixation pin 60 is introduced into thelong limb 74 of the fixation slot 18, and advanced till the fixationfluke 75 is displaced, opening the transverse limb 76 of the fixationslot 18. The suction hood 22 is revolved so that the fixation pin 60advances along the transverse limb till it reaches the short limb 77 ofthe fixation slot 18. The suction hood 22 is released allowing thefixation fluke 75 to push the fixation pin 60 into the short limb 77 ofthe fixation slot 18, securing the suction hood 22 to the deploymenttube 15.

[0124]FIGS. 30 and 31 shows a third embodiment of the coupling devicewhere the fixation mechanism comprises fixation plate 41 andperpendicularly attached to this one limb of a torsion spring 61. Thetorsion spring 61 is coplanar with the long axis of the deployment tube15. The offset block 36 in this embodiment has a linear groove 62 toaccommodate the free end 63 of the torsion spring 61. FIG. 32 shows athird embodiment of the apparatus. In this embodiment, the fixationslots 18 have a long limb 74, a traverse limb 76 and a short limb 77. Inuse, the fixation pin 60 is introduced into the long limb 74 of thefixation slot 18 and advanced till it reaches the transverse limb 76 ofthe slot 18. The suction hood 22 is revolved so that the fixation pin 60advances along the transverse limb 76 till it reaches the short limb 77of the fixation slot 18. The suction hood 22 is released allowing thetorsion spring 61 to push the fixation pin 60 into the short limb 77 ofthe fixation slot 18, securing the suction hood 22 to the deploymenttube 15 (FIG. 33).

[0125] In a fourth embodiment of the coupling device (FIGS. 30, 31) thefixation mechanism comprises a resilient wire 64 bent at an acute angle.One end of the wire 64 is perpendicularly attached to the fixation plate41, such that both limbs lie in a plane parallel to the long axis of thedeployment tube 15. The offset block 36 has a linear groove 62 toaccommodate the free end 65 of the resilient wire. In use, the fixationpin 60 is introduced into the long limb 74 (FIG. 32) of the fixationslot IS and advanced until it reaches the transverse limb 76 of the slot18. The suction hood 22 is revolved so that the fixation pin 60 advancesalong the transverse limb 76 till it reaches the short limb 77 of thefixation slot 18. The suction hood 22 is released allowing the free limb65 of the resilient wire 64 to snap back to its original orientation,pushing the fixation pin 60 into the short limb of the fixation slot 18,securing the suction hood 22 to the deployment tube 15 (FIG. 33).

[0126] In case of the embodiment of the anastomosis prosthesis shown inFIGS. 5 and 6, a modified version of the implantation procedure is used.The apparatus is not cocked. The anastomosis prosthesis is manuallyapposed against the end of the targeting-tube 14 such that the suctionhoods 22 are symmetrically apposed to the attachment member 2, beforethe anastomosis prosthesis is hypobarically secured to the deploymenttube 15 as explained above. The targeting-tube 14 is not hypobaricallysecured to the organ to be anastomosed. Nor is the anastomosisprosthesis mechanically deployed by pressing the trigger 50. Instead theanastomosis prosthesis is placed at the desired site, prior to reducingthe pressure further in the suction circuit to ensure tight appositionbetween the attachment surface 4 of the anastomosis prosthesis and theunderlying tissues.

[0127]FIG. 34 shows a fifth embodiment of the coupling device where thesuction hood 22 lacks a fixation screw 39 with plate 41. Instead, apolymer patch carrying multiple small, flexible, hooks (hook patch) 67on its surface is bonded to the offset block 36. FIG. 35 shows a fourthembodiment of the apparatus, where the fastening means are implementedby providing the outer surface 38 of the deployment tube 15 with two ormore polymer patches carrying multiple small loops on its surface (looppatch) 66. The loop patches 66 are arrayed symmetrically around thecircumference in the vicinity of the free edge 17 b of the deploymenttube 15. In use, the hook patch 67 on the offset block 36 is manuallyapposed to a loop patch 66 on the deployment tube 15, allowing the hooksto engage the loops, securing the suction hood 22 to the deployment tube15.

[0128] In a sixth embodiment of the coupling device (FIG. 34) a flatmagnet 69 is fixed to the offset block 36 of the suction hood 22. In afifth embodiment of the apparatus (FIG. 35), the outer surface 38 of thedeployment tube 15 is provided with two or more ferromagnetic patches68. The ferromagnetic patches 68 are arrayed symmetrically around thecircumference of the deployment tube 15, in the vicinity of its freeedge 17 b. In a preferred embodiment the surface of the magnet 69 has apattern on it in bas relief which complements the pattern engraved onthe ferromagnetic patch 68. In use, the magnet 69 on the offset block 36is manually apposed to a ferromagnetic patch 68 on the deployment tube15, securing the suction hood 22 to the deployment tube 15. In thisembodiment of the apparatus, the magnet 69 on the offset block ismanually apposed to a ferromagnetic patch 68 on the deployment tube 15,ensuring that the each ridge on the magnet 69 engages the correspondinggroove on the ferromagnetic patch 68.

[0129] In a preferred embodiment of the apparatus the targeting-tube isprovided with a inlet for the introduction of imaging or flowmeasurement devices. The inlet may advantageously incorporate a valvefor creating an airtight seal irrespective of whether or not an imagingor flow-measurement device is placed in the targeting-tube.

[0130]FIG. 36 shows an embodiment of the apparatus, wherein thedeployment tube 15 is provided with two or more long narrow slits 72that are parallel to the long axis of the tube 15. The slits 72 aresymmetrically arrayed around its circumference. These long narrow slitsallow reversible splaying of the free end of the deployment tube 15making it possible to attach coupling devices with radii of curvaturesubstantially larger than the radius of the deployment tube 15 itself.This feature eliminates the need to dimensionally match the deploymentinstrument to the anastomosis prosthesis being deployed.

[0131] The combination of pressure-mediated attachment and release ofthe anastomosis prosthesis, with its mechanical deployment offers anumber of advantages of relevance to the surgeon. The anastomosisprosthesis can be reversibly, yet securely, attached to the deploymentinstrument without the risk of damage associated with mechanicalfixation. Release of the prosthesis after deployment does not involvethe manipulation of movable members that may traumatise the targetorgan. The mechanical deployment mechanism allows for rapid, reliablesingle-handed delivery of the prosthesis to the target. As the couplingdevice carrying the prosthesis is detachable from the deploymentinstrument, the latter can be used with anastomosis prostheses of a widerange of sizes simply by matching the radius of curvature of thecoupling device to the size of the anastomosis prosthesis.

[0132] Thus the invention allows accurate and reliable delivery of ananastomosis prosthesis to the chosen site on the target organ, which isa vital prerequisite to the performance of externally-supportednon-sutured anastomosis.

1. Device for temporary coupling an anastomosis prosthesis to ananastomosis apparatus, comprising: a ring shaped member consisting of atleast one ring section (22), wherein each ring section (22) comprisesradial partition walls (28) defining chambers (27), and a common upperchamber limited by a roof (29), wherein the chambers (27) are adaptedfor aposing to the anastomosis prosthesis and fastening to saidprosthesis by means of a suction pressure, wherein the common upperchamber provides a channel (30) in fluid connection with the chambers(28), a tubing connection assembly (31-34) in fluid connection with saidchannel (30) for transmitting a suction pressure from a suctionapparatus to the chambers (27), and a fixation mechanism for fasteningthe ring shaped member to an anastomosis apparatus.
 2. Coupling deviceaccording to claim 1, characterised in that the fixation mechanismcomprises: an attachment plate (35) with a rectangular projection oroffset block (36), the attachment plate (35) and the offset block (36)being perforated, and a threaded fixation pin (39) through theattachment plate and the offset block (36), where the pin (39) isprovided near one end with a nut (40) and near the other end with afixation plate (41), where the offset block (36) and the fixation plate(41) are meant to be tightened against an outer (42) and an inner (38)surface respectively in a deployment tube (15) in the apparatus by meansof the pin (39).
 3. Coupling device according to claim 1, characterisedin that the fixation mechanism comprises: an attachment plate (35) witha rectangular projection or offset block (36), and a fixation pin (60)extending between the offset block (36) and a fixation plate (41), wherethe offset block (36) and the fixation plate (41) are meant to bearranged against an outer (42) and an inner (38) surface respectively ina deployment tube (15) in the apparatus.
 4. Coupling device according toclaim 3, characterised in that the fixation mechanism comprises: atorsion spring (61), where one limb of the torsion spring is attached tothe fixation plate (41) and the other limb (63) is accommodated in agroove (62) in the offset block (36), where the torsion spring (61) ismeant for pushing the fixation pin (60) into a fixation slot (18) in adeployment tube (15) in the fixation apparatus.
 5. Coupling deviceaccording to claim 4, characterised in that the fixation mechanismcomprises: a bent resilient wire (64), where one limb of the wire (64)is attached to the fixation plate (41) and the other limb (65) isaccommodated in a groove 62 in the offset block (36), where theresilient wire (64) is meant for pushing the fixation pin (60) into afixation slot (18) in a deployment tube (15) in the fixation apparatus.6. Coupling device according to claim 1, characterised in that thefixation mechanism comprises: an attachment plate (35) with arectangular projection or offset block (36), and a polymer hook or looppatch (67) bonded to the offset block (36), where the hook patch (67) ismeant for fastening the offset block (36) to a corresponding polymerloop or hook patch (66) on a deployment tube in the anastomosisapparatus.
 7. Coupling device according to claim 1, characterised inthat the fixation mechanism comprises: an attachment plate (35) with arectangular projection or offset block (36), and a flat magnet (69)bonded to the offset block (36), where the flat magnet (69) is meant forfastening the offset block (36) to at least one correspondingferromagnetic patch (68) on a deployment tube (15) in the anastomosisapparatus.
 8. Coupling device according to any of the preceding claims,characterised in that the chambers (27) are provided with a mesh (26) onthe surface adapted for aposing to the anastomosis prosthesis. 9.Deployment apparatus for use in sutureless anastomosis between twohollow organs by means of an implantable anastomosis prosthesis and aprosthesis coupling device comprising: a targeting tube (14), adeployment tube (15) provided with a fastening device for cooperationwith a fixation mechanism in the prosthesis coupling device, forfastening said prosthesis coupling device to said deployment tube (15),a flow control valve (52) for controlling fluid flow in and out of theapparatus, wherein the inlet (58) of the valve (52) is adapted forconnection to a suction apparatus, and a first outlet (55) of the valveis coupled to a fluid connecting device (57) adapted for connection to acorresponding tubing connection assembly (34) in the anastomosiscoupling device (22), a flow control lever (53) for controlling flowthrough said valve (52), and a trigger (50) for displacing thedeployment tube (15) in relation to the body of the apparatus, a device(59) for connecting the apparatus to a suction apparatus.
 10. Apparatusaccording to claim 9, characterised in that the fastening deviceconsists of at least one fixation slot (18) extending from the edge (17b) of the deployment tube.
 11. Apparatus according to claim 10,characterised in that each fixation slot (18) comprises a long limb(74), a fixation fluke (75), a transverse limb (76) and a short limb(77), where the fixation fluke (75) is meant for securing a fixation pin(60) in a fixation mechanism in the prosthesis coupling device (22) intothe short limb (77) of the fixation slot (18).
 12. Apparatus accordingto claim 10, characterised in that each fixation slot (18) comprises along limb (74), a transverse limb (76) and a short limb (77), where theshort limb (77) is meant for receiving a fixation pin (60) in a fixationmechanism in the prosthesis coupling device (22).
 13. Apparatusaccording to claim 9, characterised in that the fastening deviceconsists of at least one loop or hook polymer patch (66) arranged on thedeployment tube (15) for fastening to a corresponding hook or loop pacth(67) in a fixation mechanism in the prosthesis coupling device (22). 14.Apparatus according to claim 9, characterised in that the fasteningdevice consists of at least one ferromagnetic patch (68) arranged on thedeployment tube (15) for fastening to a corresponding magnet (69) in afixation mechanism in the prosthesis coupling device (22).
 15. Apparatusaccording to one of the preceding claims 9-14, characterised in that itincludes an inlet (70) for introduction of imaging or flow measuringdevices.
 16. Apparatus according to any of the preceding claims 9-15,characterised in that a second outlet (54) of the flow control valve(52) is coupled via a side arm (16) to the inside of the targeting tube(14) for transmitting a negative pressure to said targeting tube (14).17. Apparatus according to one of the preceding claims, characterised inthat it comprises a prosthesis coupling device according to one ofclaims 1-8 as an integrated element of the apparatus.
 18. Anastomosisprosthesis comprising: a first tubular member (1) attached to a flatmember (2) wherein the prosthesis comprises a second tubular memberattached to the first tubular member and adapted to act as instrumentinlet.